Myrtue Medical Center Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on January 9, 2026. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6000 - 42 C.F.R 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute, the laboratory failed to successfully participate in two out of three consecutive testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- events for the analyte, fibrinogen. The laboratory had unsatisfactory scores for 2025 event 1 and 2025 event 3. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two out of three consecutive testing events for the analyte, fibrinogen. The findings include: 1. For 2025 event 1, the laboratory received an unsatisfactory performance score of 40% for the analyte, fibrinogen. 2. For 2025 event 3, the laboratory received an unsatisfactory performance score of 60% for the analyte, fibrinogen. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2025 event 1 and 2025 event 3), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 1:00 pm on 11/13/2020, the laboratory failed to retain copies of the Abbott Cell-Dyn Ruby instrument QC assay sheets for three out of three lot numbers of hematology QC (L0055, N0055, and H0055). The findings include: 1. During the survey, hematology QC records were reviewed from April 2020. 2. QC records indicated that the following lot numbers of QC were in use during April 2020: L0055, N0055, and H0055. 3. At the time of the survey, personnel identifier #1 confirmed that the manufacturer's assay sheets were not available for hematology QC lot numbers L0055, N0055, and H0055. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of hematology quality control records, patient testing records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Report) at approximately 1:00 pm on 11/13/2020, the laboratory failed to meet hematology requirements for: performing two control materials of different concentrations as specified in the standard D5447;ensuring quality control results are acceptable prior to reporting patient test results as specified in the standard D5481; and taking

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Illumigene maintenance log and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 10/12/2018, the laboratory failed to perform and document daily maintenance on the Illumigene analyzer for 30 out of 30 days and monthly maintenance for one out of one month of patient testing (September 2018). The findings include: 1. The Illumigene maintenance log stated the laboratory must daily: *Perform the self check test *Record the heat block temperature *Clean the analyzer 2. The Illumigene maintenance log stated the laboratory must monthly verify the standards in block A and block B. 3. At the time of the survey, the laboratory did not have documentation of the daily and monthly maintenance being performed on the Illumigene analyzer from September 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --